PMC:7536913 / 11500-12631 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7536913","sourcedb":"PMC","sourceid":"7536913","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7536913","text":"Fit for purpose and risk‐based CMC requirements\nAs preclinical and clinical phases are streamlined, chemistry and manufacturing controls (CMC) data must equally be fit for purpose. In order to rapidly accelerate the development and manufacturing scale‐up of COVID‐19 treatments and vaccines, regulators have employed risk‐based decisions to defer certain CMC requirements to later stages of development or even post approval. There are long‐standing challenges to accelerating manufacturing aspects under expedited programs, and the COVID‐19 experience further emphasizes the need for analogous regulatory flexibility. For instance, using judgment‐based clinically meaningful specifications or deferring longer‐term stability data until the postmarket setting. Moreover, allowing companies to report more postapproval changes within their quality system (vs. submitting for regulatory approval) would allow for more manufacturing flexibility and ability to react to supply challenges globally more quickly, as outlined in ICH Q12 Guideline “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Development.”","divisions":[{"label":"title","span":{"begin":0,"end":47}}],"tracks":[{"project":"LitCovid-PD-UBERON","denotations":[{"id":"T7","span":{"begin":246,"end":251},"obj":"Body_part"}],"attributes":[{"id":"A7","pred":"uberon_id","subj":"T7","obj":"http://purl.obolibrary.org/obo/UBERON_0002542"},{"subj":"T7","pred":"source","obj":"LitCovid-PD-UBERON"}]},{"project":"LitCovid-PD-MONDO","denotations":[{"id":"T32","span":{"begin":31,"end":34},"obj":"Disease"},{"id":"T34","span":{"begin":138,"end":141},"obj":"Disease"},{"id":"T36","span":{"begin":258,"end":266},"obj":"Disease"},{"id":"T37","span":{"begin":355,"end":358},"obj":"Disease"},{"id":"T39","span":{"begin":533,"end":541},"obj":"Disease"}],"attributes":[{"id":"A32","pred":"mondo_id","subj":"T32","obj":"http://purl.obolibrary.org/obo/MONDO_0008094"},{"id":"A33","pred":"mondo_id","subj":"T32","obj":"http://purl.obolibrary.org/obo/MONDO_0015279"},{"id":"A34","pred":"mondo_id","subj":"T34","obj":"http://purl.obolibrary.org/obo/MONDO_0008094"},{"id":"A35","pred":"mondo_id","subj":"T34","obj":"http://purl.obolibrary.org/obo/MONDO_0015279"},{"id":"A36","pred":"mondo_id","subj":"T36","obj":"http://purl.obolibrary.org/obo/MONDO_0100096"},{"id":"A37","pred":"mondo_id","subj":"T37","obj":"http://purl.obolibrary.org/obo/MONDO_0008094"},{"id":"A38","pred":"mondo_id","subj":"T37","obj":"http://purl.obolibrary.org/obo/MONDO_0015279"},{"id":"A39","pred":"mondo_id","subj":"T39","obj":"http://purl.obolibrary.org/obo/MONDO_0100096"},{"subj":"T32","pred":"source","obj":"LitCovid-PD-MONDO"},{"subj":"T34","pred":"source","obj":"LitCovid-PD-MONDO"},{"subj":"T36","pred":"source","obj":"LitCovid-PD-MONDO"},{"subj":"T37","pred":"source","obj":"LitCovid-PD-MONDO"},{"subj":"T39","pred":"source","obj":"LitCovid-PD-MONDO"}]},{"project":"LitCovid-PD-CHEBI","denotations":[{"id":"T9","span":{"begin":31,"end":34},"obj":"Chemical"},{"id":"T10","span":{"begin":138,"end":141},"obj":"Chemical"},{"id":"T11","span":{"begin":355,"end":358},"obj":"Chemical"}],"attributes":[{"id":"A9","pred":"chebi_id","subj":"T9","obj":"http://purl.obolibrary.org/obo/CHEBI_85146"},{"id":"A10","pred":"chebi_id","subj":"T10","obj":"http://purl.obolibrary.org/obo/CHEBI_85146"},{"id":"A11","pred":"chebi_id","subj":"T11","obj":"http://purl.obolibrary.org/obo/CHEBI_85146"},{"subj":"T9","pred":"source","obj":"LitCovid-PD-CHEBI"},{"subj":"T10","pred":"source","obj":"LitCovid-PD-CHEBI"},{"subj":"T11","pred":"source","obj":"LitCovid-PD-CHEBI"}]},{"project":"LitCovid-PubTator","denotations":[{"id":"101","span":{"begin":258,"end":266},"obj":"Disease"},{"id":"102","span":{"begin":533,"end":541},"obj":"Disease"},{"id":"103","span":{"begin":1022,"end":1025},"obj":"Disease"}],"attributes":[{"id":"A101","pred":"tao:has_database_id","subj":"101","obj":"MESH:C000657245"},{"id":"A102","pred":"tao:has_database_id","subj":"102","obj":"MESH:C000657245"},{"id":"A103","pred":"tao:has_database_id","subj":"103","obj":"MESH:D002543"},{"subj":"101","pred":"source","obj":"LitCovid-PubTator"},{"subj":"102","pred":"source","obj":"LitCovid-PubTator"},{"subj":"103","pred":"source","obj":"LitCovid-PubTator"}],"namespaces":[{"prefix":"Tax","uri":"https://www.ncbi.nlm.nih.gov/taxonomy/"},{"prefix":"MESH","uri":"https://id.nlm.nih.gov/mesh/"},{"prefix":"Gene","uri":"https://www.ncbi.nlm.nih.gov/gene/"},{"prefix":"CVCL","uri":"https://web.expasy.org/cellosaurus/CVCL_"}]},{"project":"LitCovid-sentences","denotations":[{"id":"T75","span":{"begin":0,"end":47},"obj":"Sentence"},{"id":"T76","span":{"begin":48,"end":180},"obj":"Sentence"},{"id":"T77","span":{"begin":181,"end":425},"obj":"Sentence"},{"id":"T78","span":{"begin":426,"end":618},"obj":"Sentence"},{"id":"T79","span":{"begin":619,"end":760},"obj":"Sentence"},{"id":"T80","span":{"begin":761,"end":1131},"obj":"Sentence"}],"namespaces":[{"prefix":"_base","uri":"http://pubannotation.org/ontology/tao.owl#"}],"attributes":[{"subj":"T75","pred":"source","obj":"LitCovid-sentences"},{"subj":"T76","pred":"source","obj":"LitCovid-sentences"},{"subj":"T77","pred":"source","obj":"LitCovid-sentences"},{"subj":"T78","pred":"source","obj":"LitCovid-sentences"},{"subj":"T79","pred":"source","obj":"LitCovid-sentences"},{"subj":"T80","pred":"source","obj":"LitCovid-sentences"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"LitCovid-PD-UBERON","color":"#93ecdd","default":true},{"id":"LitCovid-PD-MONDO","color":"#ecc393"},{"id":"LitCovid-PD-CHEBI","color":"#a993ec"},{"id":"LitCovid-PubTator","color":"#96ec93"},{"id":"LitCovid-sentences","color":"#ec93b0"}]}]}}